Drugs

CGMP Violations Seen in Anhui Hanbon Inspection

A 2/24-2/28 FDA inspection at the Anhui Hanbon Daily Chemical Co., Ltd., drug manufacturing facility in Huainan Shi, Anhui Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/11 Warning Letter says the specific violations were:

failure to test samples of each component for specific identity and conformity with all appropriate written specifications for purity, strength, and quality;
failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods;
failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
failure to establish written procedures for production and process control designed to assure that the manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess.

FDA recommends the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Anhui Hanbon was told to correct violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome